FDAClass IIOctober 22, 2025

CX Preconnect with TENACIO Pump without InhibiZone recall

CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);

Why was CX Preconnect with TENACIO Pump without InhibiZone recalled?

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

1. UPN: 72404486 (15CM IP); UDI-DI: 00191506021658; Lot numbers: 1100676851, 1100676852; 2. UPN: 72404488 (21CM IP); UDI-DI: 00191506021672; Lot numbers: 1100717673;

Product
CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);
Recalling firm
Boston Scientific Corporation
Quantity
1 unit
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Recall date
October 22, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls